BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970020 · Supplement: S005 · Decision Feb 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS
    PMA Number
    P970020
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 18, 1999
    Date Received
    August 17, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to add the indication for abrupt or threatened abrupt closure to the product labeling for the ACS Multi-Link(TM) (OTW, RX HP(TM), and OTW HP(TM)), ACS Multi-Link RX, ACS Multi-Link (RX and OTW) Duet(TM) Coronary Stent Systems (CSS); and approval for additional stent sizes for the ACS Multi-Link RX (stents with 2.5 mm diameter or 35 mm length) and ACS Multi-Link (RX and OTW) Duet(TM) (stents with 2.5 mm diameter or 38 mm length)CSS. These devices are indicated for use as follows: The ACS Multi-Link(TM) OTW, RX HP(TM), and OTW HP(TM) CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 20 mm) with a reference vessel diameter ranging from 3.0 mm to 3.75 mm; due to discrete restenotic native coronary artery lesions (length < 20mm) with a reference vessel deameter ranging from 3.0 mm to 3.75mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length < 20mm) with a reference vessel diameter ranging from 3.0mm to 3.75mm); and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. The ACS Multi-Link(TM) RX CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; due to discrete restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length <32mm) with a reference vessel diameter raning from 2.5mm to 3.5mm; and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. Note: The 2.5mm diamter and 35mm length stents are indicated solely for use in patients with abrupt or threatened

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAF Stent, Coronary